News
Taipei, Feb 9, 2026 — Golden Biotechnology Corp. (TPEx: 4132, "Golden Biotech") announces the successful completion of its Investigational New Drug (IND) submission to the US FDA for a Phase 3 trial of Antroquinonol (Hocena®) in First-line Metastatic Pancreatic Cancer.
The US FDA has reviewed the submission and issued no Clinical Hold, clearing the path for trial initiation
The Company submitted its Phase III clinical trial application to the FDA on December 31, 2025. The Company plans to proceed with submission to the Institutional Review Board (IRB) and other required regulatory processes in preparation for initiation of the Phase III clinical trial.
The planned Phase III study will evaluate Antroquinonol (Hocena) in combination with standard-of-care chemotherapy (Nab-paclitaxel plus Gemcitabine) as a first-line treatment for patients with metastatic pancreatic cancer. In a previously completed Phase II clinical study, Antroquinonol (Hocena) demonstrated a median overall survival (mOS) of 14.1 months. For reference, the pivotal Phase III study of Nab-paclitaxel plus Gemcitabine reported a median overall survival of 8.5 months.
FORWARD LOOKING STATEMENTS
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